K052444 is an FDA 510(k) clearance for the INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on September 20, 2005, 14 days after receiving the submission on September 6, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K052444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2005 |
| Decision Date | September 20, 2005 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY — Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |